Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)

NCT06354049 | Completed DMC

• 1 other identifier: CASE3Z24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population.

Conditions

Cancer Pain; Oncology Pain

Keywords

Reiki

Outcome Measures

Primary Outcomes (6)

• Recruitment rate as measured by the percentage of participants enrolled

  Calculated by total number of participants enrolled/ total number of participants eligible and 90% is considered successful for the recruitment rate.

  8 weeks post enrollment

• Retention rate as measured by the number of participants retained until the final survey point

  Calculated by number of participants retained until the final survey time point / number of participants enrolled. 70% of participant retention until the final survey time point will be considered successful.

  8 weeks post enrollment

• Attendance rate as measured by number of sessions attended per 6 sessions

  Total number of sessions attended per 6 sessions. Attendance rate of \>/= 70% will be considered successful

  8 weeks post enrollment

• Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention

  Number of participants treated in manner consistent with intervention/total number of participants enrolled

  8 weeks post enrollment

• Acceptability as measured by the patient mean of participant satisfaction survey

  As assessed by participants mean for the Participants' satisfaction survey with the Reiki sessions, measured on a scale from 0 (Not at all satisfied) to 10 (Completely satisfied)

  8 weeks post enrollment

• Data completeness rate

  Data completeness of \>/= 90% is considered satisfactory

  8 weeks post enrollment

Secondary Outcomes (2)

• Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score

  Baseline, 8 weeks

• Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale

  Upto 8 weeks

Study Arms (1)

Reiki therapy

EXPERIMENTAL

This is a feasibility single arm trial of Reiki for oncology participants.

Other: Reiki

Interventions

Reiki OTHER

Reiki, originating in Japan, is a biofield therapy where a skilled practitioner places their hands on or above the body of the recipient or themselves to induce relaxation and promote healing.

Reiki therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 89.
• Neoplasm diagnosis (i.e., ICD-10 C00 - D49) confirmed in electronic health record (EHR)/Caisis
• Receiving care at a UH Connor Whole Health Integrative Oncology Clinic.
• Reporting at least three ESAS symptoms ≥4/10 at baseline screening including fatigue and ≥2 other symptoms on the 9-item questionnaire.
• Able to speak and understand English.
• Has an email address, and access to a computer with internet and/or a mobile device with a functioning data plan

You may not qualify if:

• Significant cognitive impairment that has not been corrected.
• Significant visual impairment that has not been corrected.
• Unable to provide informed consent.
• Active psychosis.
• Pregnancy.
• Metastatic disease.
• Reiki therapy within 3 months of study enrollment
• Active immunotherapy, chemotherapy, or radiation treatment, or completed within 3 months before study start. Aromatase inhibitors and tamoxifen are exceptions.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Santosh Rao, MD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: August 7, 2024
• Primary Completion: July 17, 2025
• Study Completion: August 7, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)